This invention is related to nasal dilators and particularly to a surgically implantable nasal dilator, having an internal generally open "V"-shaped skeleton structure encased within an external biocompatible covering material, which urges the wall tissues of the nasal passageways outward, thereby opening the nasal passageways and reducing the likelihood of nasal passageway blockage during inhalation.
Nasal valve dysfunction is an extremely prevalent medical condition, particularly in the geriatric population. To compensate for this condition, external nasal dilators, such as devices sold under the "Breathe Right" trademark by CNS, Inc., 1250Park Road, Chanhassen, Minn. 55317, have begun to receive widespread commercial acceptance. Devices of this type are shown in U.S. Pat. No. 5,533,449. Breathe Right.TM. external nasal dilators have been marketed to the geriatric population, as well as to athletes and patients with sleep apnea or snoring. Other types of external nasal dilators are known, such as those described in U.S. Pat. No. Re. 35,408.
A significant disadvantage of external nasal dilators is that they need to be affixed externally each time they are used. Because they are attached to the exterior of the face, typically by an adhesive, they are quite noticeable cosmetically and are normally not reusable.
Various devices which are intended to be manually inserted into the nasal cavities of the user to open up the nasal passageways are also known. These devices are commonly known as nostril expanders and are described, for instance, in U.S. Pat. Nos. 851,048 and 1,597,331. These devices are intended to inserted by the user prior to each use and removed by the user at the end of each use. These types of nostril expanders are, however, quite uncomfortable to wear. Because they are typically made from a material that is not adequately biocompatible, they can cause nasal tissue irritation and itching. Due to the physical discomfort caused by wearing these types of devices, they cannot typically be left inserted for long periods of time, such as while the user sleeps.
An improved nasal dilator is therefore desirable that would provide permanent relief of nasal valvular dysfunction and would not require affixation each time it is used. It is also desirable to provide an improved nasal dilator that is not visible during use. It is further desirable to provide an improved nasal dilator that may be permanently implanted and that will not cause physical discomfort to the user.
In accordance with the present invention, an surgically implantable nasal dilator is disclosed having an internal open "V"-shaped skeleton structure encased within an external biocompatible sheath material. The surgically implantable nasal dilator is quite small and is easily implantable into the nasal tissues of a user through a simple 0.5 centimeter central nasal incision.
The center portion of the surgically implantable nasal dilator (i.e. the middle portion of the "V") may be positioned external to the upper lateral cartilages of the user. The opposing ends of the device (i.e. the opposed ends of the "V") may be positioned superior to the lower lateral cartilages of the user. The arms of the device (i.e. the portions between the central portion and the opposing ends of the device) are typically compressed toward each other during implantation and when released, these arms produce a force which urges the wall tissues of the nasal passageways outwardly, thereby opening the nasal passageways of the user and reducing the likelihood of nasal passageway blockage during inhalation.
The surgically implantable nasal dilator is fabricated from two types of materials that have distinctly different required material properties. The internal skeleton structure of the surgically implantable nasal dilator is a structural element designed to produce the outward opening force on the wall tissues of the user. The internal skeleton structure must therefore be constructed of a structural material capable of producing this outward opening force. The internal skeleton structure is encased within an external sheathing material which is intended to reduce the likelihood of tissue irritation or foreign body rejection problems caused by the implanted surgically implantable nasal dilator. The external sheathing material must therefore be biocompatible with human facial tissue. The performance characteristics of these materials and a description of suitable materials are discussed in more detail below.
After being implanted, the surgically implantable nasal dilator may effectively and permanently solve a patent's nasal valvular dysfunction. The device would not be visible and would be virtually undetectable after it is implanted. Increased airway performance and decreased nasal passageway blockage would be enjoyed around the clock instead of those relatively short periods in which an external nasal dilator is worn. Once implanted, the surgically implantable nasal dilator can be comfortably worn for a lifetime and can provide significant reductions in nasal airflow problems.
Further objects, features and advantages of the invention will become apparent from a consideration of the following description and the appended claims when taken in connection with the accompanying drawings.